MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY DELTA SHUNT KIT, SMALL PERFORMANCE LEVEL 2.0; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	25131-2
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that after 2 weeks of shunt installation, the valve was not working properly.It was stated that it stopped working with pressure 140-160, but only up to 170.The valve was explanted and replaced with another valve.The patient was implanted for triventricular hydrocephalus.
Additional Manufacturer Narrative
The returned valve was patent.The valve met the requirements for leak, siphon, and reflux.The valve did not meet the requirements for pressure-flow and preimplantation testing.Biological debris was observed on the interior of the valve.The instructions for use cautions, ¿shunt obstruction may occur in any of the components of the shunt system.The system may become internally occluded due to tissue fragments, blood clots, tumor cell aggregates, bacterial colonization or other debris.¿ all valves are 100% inspected at the time of manufacture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: DELTA SHUNT KIT, SMALL PERFORMANCE LEVEL 2.0
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 9293236
• Report Number: 2021898-2019-00400
• Device Sequence Number: 2002754
• Product Code: JXG
• UDI-Device Identifier: 00643169472778
• UDI-Public: 00643169472778
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K902783
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 25131-2
• Device Catalogue Number: 25131-2
• Device Lot Number: E09997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 12/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 3 MO
• Patient Weight: 4